In March 2022, the In re Zostavax MDL court entered a Lone Pine order requiring plaintiffs who claimed to have developed shingles as a result of using the Zostavax vaccine to produce certain test results supporting causation....more
After publishing the proposed regulation nearly two years ago, the FDA has issued its final rule that will make its regulatory framework more closely aligned with the international framework used by many other regulatory...more
The Committee Notes to the newly implemented amendments to Federal Rule of Evidence 702 make clear that the “[j]udicial gatekeeping” of expert evidence is “essential.” Federal courts in New York have played an important role...more
Earlier this year, we discussed the Eastern District of Pennsylvania’s decision to enter a Lone Pine order – that is, a case management order that requires all plaintiffs to produce evidence establishing specific elements of...more
A developing line of cases across the nation may have large implications for medical device manufacturers defending against failure-to-warn claims. While a treating physician’s failure to read or rely on the manufacturer’s...more
On March 14, 2022, a bipartisan trio of U.S. Senators introduced a bill (S.3830) that would require manufacturers to provide the tools and documentation necessary for consumers and third parties to repair electronic...more
The FDA has recently published a proposed regulation that will make its regulatory framework more closely aligned with the international framework used by other regulatory authorities around the world. If finalized, this...more
Although product liability actions are governed by state tort law, they frequently find their way into federal court on diversity jurisdiction. In such actions, federal law provides the procedural rules and state law provides...more